A new, minimally invasive system which uses radiofrequency energy instead of open surgery to create arteriovenous fistulas for patients needing hemodialysis, is reliable, with minimal complications, according to data published in the American Journal of Kidney Disease.
A one year, single arm, prospective study of 80 pre-dialysis and dialysis patients from nine centers in Canada, Australia, and New Zealand showed that an AV fistula was created successfully in 98 percent of all cases, with 87 percent being physiologically suitable for dialysis within three months of creation by this new magnet-based endovascular technology. Sixty-four percent of the AV fistulas were functionally used for dialysis within 12 months.
Thrombosis or clots formed in 1.8 percent of AV-fistulas within three months and 10.5 percent within 12 months – lower than that reported in current AV-fistulas created by open surgery. Studies have reported that from 14 to 26 per cent of traditional fistulas had clots within 12 months, according to background infomartion reported in the study.
“Chronic kidney patients currently do not have a minimally invasive option for creating AV-fistulas and yet it could reduce a significant barrier for patients to have an AV-fistula, which is the preferred access for hemodialysis. Patients often refuse AV-fistula creation because they do not want to undergo open surgery, and this technology can provide another option for patients,” said Charmaine Lok, MD, Medical Director of the Chronic Kidney Diseases and Hemodialysis Programs at the Toronto General Hospital, University Health Network principal investigator of the trial.
About the procedure
Using the everlinQ endoAVF System by TVA Medical, one magnetic catheter was inserted into the ulnar artery via the brachial artery, and one magnetic catheter was inserted into the ulnar vein via the brachial vein. The vessels were drawn together by the magnets. A small burst of radiofrequency energy, given through the catheters, was then used to create a connection between the artery and vein, creating the AV-fistula. The catheters were then removed leaving no surgical scar. These study procedures were performed on outpatients who did not need general anesthesia.
The everlinQ endoAVF System is under review with the U.S. Food and Drug Administration and is approved for use in Canada and Europe.
The study, entitled, “Endovascular Proximal Forearm Arteriovenous Fistula for Hemodialysis Access: Results of the prospective, multicenter Novel Endovascular Access Trial (NEAT),” is published online in the American Journal of Kidney Disease.
“This novel technology is a substantial benefit to our hemodialysis patients,” said Dheeraj Rajan, MD, the co-primary investigator in the study and Vascular/Interventional Radiologist at University Health Network’s Joint Department of Medical Imaging.“We can now access veins and arteries that otherwise would not be easily accessible via surgery, and we can do this in a safe, quick way that is easy for our patents to tolerate.”